FDA warns of possible fetal risk linked to NSAIDs
Click Here to Manage Email Alerts
The FDA announced that manufacturers of nonsteroidal anti-inflammatory drugs will be required to update their boxed warning to list potential fetal risk in women using the medications 20 weeks or later in their pregnancies.
The agency notified health care professionals of reports of rare, but serious, kidney problems and low amniotic fluid levels in the fetuses of women using NSAIDs in the second half of their pregnancies, which could increase the likelihood of pregnancy-related complications.
Source: Adobe Stock.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of the FDA's Center for Drug Evaluation and Research, said in the press release. “To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
The label change applies to both prescription and over-the-counter NSAIDs, such as ibuprofen, naproxen, diclofenac and celecoxib, which are intended to reduce pain, decrease fever, prevent blood clots and decrease inflammation. Low-dose aspirin, however, is exempt from the required label change, the FDA noted.
According to the agency, oligohydramnios — low levels of amniotic fluid — can be detected days or weeks after starting these medications, but it could be detected as early as two days after initiating regular NSAID use. The FDA noted that this condition typically resolves itself if the woman discontinues the medication.
“For prescription NSAIDs, the FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid and to recommend that NSAID use be limited between about 20 weeks to 30 weeks of pregnancy because of this risk,” the FDA said in the release. “Warnings to avoid taking NSAIDs after about 30 weeks of pregnancy are already included in the prescribing information because taking these medications during this time may lead to heart issues in the unborn baby.”
However, the agency said if a health care provider deems NSAID use necessary between 20 weeks to 30 weeks of pregnancy, its use should be restricted to the lowest effective dose and shortest duration. Likewise, the manufacturers of OTC NSAIDs for adult use will implement similar updates to their Drug Facts labels.
Perspective
Back to Top
David A. McLain, MD, FACP, FACR
In rheumatology, we use NSAIDs on a daily basis. In pregnant females, I usually defer to the obstetrician regarding continuing medications I have prescribed — with the exception of hydroxychloroquine, prednisone and certolizumab.
This warning from the FDA on the development of oligohydramnios in pregnancy with the use of NSAIDs after 20 weeks of gestation was new to many of us, despite being first reported in 1980. Most of the amniotic fluid is produced by the fetus’ kidneys after 20 weeks and NSAIDs can suppress fetal kidney function, just as in adults. The resultant drop in amniotic fluid causes oligohydramnios and can lead to fetal deformation, umbilical cord compression and pulmonary hypoplasia.
NSAID use in early pregnancy increases the risk of miscarriage and malformations. Fetal and neonatal adverse effects affecting the brain, kidney, lung, skeleton, gastrointestinal tract and cardiovascular system have also been reported after prenatal exposure to NSAIDs. Exposure to NSAIDs after 30 weeks’ gestation is also associated with an increased risk of premature closure of the fetal ductus arteriosus. NSAIDs should be given in pregnancy only if the maternal benefits outweigh the potential fetal risks, at the lowest effective dose and for the shortest duration possible.
Read more about
Click Here to Manage Email Alerts